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I have full control of illness at home, says South Yorkshire patient - The Star

Published on Saturday 2 June 2012 07:00

FIVE times a week, Gavin Peckitt settles into an armchair in his South Yorkshire home and hooks himself up to his dialysis machine.

The 64-year-old’s kidneys have failed and for the last two years he has relied on dialysis to survive.

The father-of-two said: “For the first five months I was coming into the Northern General Hospital, three times a week.

“When you first go on dialysis you are pretty ill. And I was pretty depressed as well.

“You just think, ‘give me the dialysis and get it over with’. But after a while I wanted control.”

Gavin, who lives in Herringthorpe, Rotherham, with his wife Joyce, 63, is now one of more than 100 kidney patients in South Yorkshire in North Derbyshire trained to give themselves dialysis, using machines in their own homes.

He said: “It means I can juggle things - arrange my dialysis myself.”

And Gavin is using the machine more than he was in hospital - five times a week or 15 hours, rather than the three times a week the hospital was able to give him.

“On dialysis I don’t feel there is anything wrong with me,” he said. “I do 50 laps of the pool twice a week, I feel fine.

“There are problems with it - its very tiring for my wife - but its better than coming to the hospital.”

Sheffield Teaching Hospitals, which runs the renal service for South Yorkshire, North Derbyshire and North Lincolnshire, is championing home dialysis as part of a new move to get people out of hospitals, and treat them in their own homes.

As well as finding new ways to treat people out of hospital, the trust is trying to shorten patients stays where they do have to come in.

In the Royal Hallamshire’s urology department, treatments such as vasectomies and cystoscopies - which used to be done in theatre - are now done as day treatments.

Consultant urological surgeon Ken Hastie said: “A lot of what we are doing is trying to reduce hospital stays.

“We are using our new lithotripsy machine to break down kidney stones, which is a non-invasive method that uses shockwaves.

“Twenty years ago, this was done using open surgery, then we used an endoscopy, an invasive method that involved a two or three-day stay.

“Lithotripsy, where it is suitable, means you have patients back in their home environment, which is better for patient outcomes.”

Michael Harper, general manager of the hospitals’ surgical services division, said: “We are really condensing down minor procedures - having people in and out in a day.

“And some complex procedures, that used to take two weeks, are now taking three days.

“One way we are doing this is by giving people physiotherapy exercises earlier - getting people practising the moves before they even go into surgery.”

Exclusive: Sheffield patients stay too long in hospital

PATIENTS will spend less time in Sheffield hospitals and more time being treated at home, under sweeping plans to transform the way health services are run, writes Ben Spencer.

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Investigational Anti-PD-1 Immunotherapy BMS-936558 Showed Clinical Activity In ... - TheStreet.com (press release)

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Investigational Anti-PD-1 Immunotherapy BMS-936558 Showed Clinical Activity in ... - MarketWatch (press release)

PRINCETON, N.J, Jun 02, 2012 (BUSINESS WIRE) -- --Anti-PD-1 Registrational Development Programs for NSCLC and RCC to Start this Year; Metastatic Melanoma to Start Late 2012, Early 2013

--Phase 1 Data on Second Investigational Immunotherapy (Anti-PD-L1) Also Published in NEJM and Presented at ASCO

--Data Broaden Scientific Understanding of the Field of Immuno-Oncology

Bristol-Myers Squibb Company /quotes/zigman/220498/quotes/nls/bmy BMY -0.03% today announced interim results from the expanded Phase 1 dose-ranging study 003 (n=296) of its investigational anti-PD-1 immunotherapy (BMS-936558), which showed clinical activity in patients with previously-treated non small-cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma (RCC). Anti-PD-1 is a fully-human antibody that targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1. Objective response rates (ORs) across dose cohorts, as measured by standard RECIST criteria, ranged from 6% to 32% in NSCLC, 19% to 41% in metastatic melanoma and 24% to 31% in RCC. Most responses were durable.

Drug-related serious adverse events occurred in 11% of patients who received BMS-936558. Drug-related adverse events of special interest, defined as those with potential immune-related etiology, were sometimes severe and life-threatening.

The data on anti-PD-1 were published today in the New England Journal of Medicine(1) and featured in four oral presentations at the 48th Annual Meeting of the American Society of Clinical Oncology (Abstract # 2509, 4505, 7509 and 8507). Additionally, abstracts from the NSCLC cohort (Abstract# 7509) and the melanoma cohort (Abstract #8507) of study 003 have been chosen for the Best of ASCO(R) educational program.

"Results from this Phase 1 study of anti-PD-1 showed clinical activity across NSCLC, metastatic melanoma and RCC, adding to our scientific understanding of the potential of immuno-oncology as a therapeutic approach in the treatment of cancer," said Dr. Thomas J. Lynch, Jr., director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital at Yale-New Haven, which was involved in the clinical trials. "These data are encouraging and support further investigation of anti-PD-1 in large-scale, randomized Phase 3 trials."

"Immuno-oncology is a prioritized area of research and development at Bristol-Myers Squibb and we plan to initiate registrational studies for anti-PD-1 in NSCLC and RCC this year and late 2012, early 2013 for metastatic melanoma," said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. "Our commitment to advancing the science of immuno-oncology is underscored by the data presented at ASCO and published in the New England Journal of Medicine, our ongoing development programs for immuno-oncology assets including YERVOY(R) (ipilimumab) and anti-PD-1, and the investment in the International Immuno-Oncology Network, a collaboration with leading cancer research centers."

Data on a second investigational immunotherapy from Bristol-Myers Squibb, anti-PD-L1 (BMS-936559), were also published today in the New England Journal of Medicine(2) and featured in an oral presentation at ASCO (Abstract # 2510). BMS-936559 is fully-human antibody that targets one of the immunosuppressive ligands for PD-1, PD-L1, which is often expressed on tumor, stromal and immune cells.

Through a collaboration agreement with Ono Pharmaceutical, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize anti-PD-1 (BMS-936558/ONO-4538) globally except in Japan, Korea and Taiwan where Ono has retained all rights to the compound.

Study 003 Interim Results

Objective responses, as measured by standard RECIST criteria, were observed in patients treated with BMS-936558 across dose cohorts and across the NSCLC (6% to 32%), metastatic melanoma (19% to 41%) and RCC (6% to 32%) tumor types. Most responses were durable with response durations greater-than or equal to 1 year in 65% of responders with greater-than or equal to 1 year follow-up.

The spectrum, frequency, and severity of treatment-related adverse events (AEs) were generally similar across tested dose levels. Common drug-related AEs included fatigue, rash, diarrhea, decreased appetite and nausea, with Grade 3-4 AEs observed in 14% of patients. Drug-related AEs of special interest, defined as those with potential immune-related etiologies, included pneumonitis, vitiligo, colitis, hepatitis, hypophysitis and thyroiditis. Hepatic or gastrointestinal AEs were managed with treatment interruption and administration of corticosteroids, as needed. Endocrine disorders were managed with replacement therapy. Drug-related pneumonitis occurred in 9 of 296 (3%) patients. Grade 3-4 pneumonitis developed in 3 (1%) patients and was associated with 3 drug-related deaths.

About Study 003

Study 003 is a dose-ranging Phase 1 study (n=296) evaluating the safety, antitumor activity and pharmacokinetics of BMS-936558 in patients with advanced melanoma (n=104), non-small cell lung cancer (n=122), renal cell carcinoma (n=34), castration-resistant prostate cancer (n=17) and colorectal cancer (n=19).

Eligible patients were administered BMS-936558 as an intravenous infusion every 2 weeks of each 8-week treatment cycle. Cohorts of three to six patients per dose level (0.1, 0.3, 1.0, 3.0 or 10 mg/kg) were enrolled sequentially. Patients continued treatment less-than or equal to 2 years (12 cycles), unless they experienced complete response, unacceptable toxicity, progressive disease or withdrew consent. In clinically stable patients, treatment could be continued beyond apparent initial disease progression until confirmed progression, as defined by proposed immune response criteria. Patients with stable disease (SD) or an ongoing OR at the completion of treatment were followed for less-than or equal to 1 year and offered retreatment for one additional year if their disease progressed. OR was defined as complete (CR) or partial response (PR).

Immuno-Oncology at Bristol-Myers Squibb

Immuno-oncology, which focuses on the scientific potential of harnessing the unique properties of the immune system to fight cancer, is a prioritized area of research and development at Bristol-Myers Squibb. The Company is committed to leading advances in this important field of research and is exploring a variety of innovative compounds and immunotherapeutic approaches to help address significant unmet medical needs in a broad range of cancers. More information can be found at www.BMSImmunoOncology.com .

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com , or follow us on Twitter at http://twitter.com/bmsnews .

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the all of the compounds described in this release will move from exploratory development into full product development, that the clinical trials of these compounds will support regulatory filings, or that all of the compounds will receive regulatory approvals or, if approved, that they will all become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2011, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

(1) Topalian et al the Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center.

(2) Brahmer et al the Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center.

SOURCE: Bristol-Myers Squibb




        
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